CTX112 for B-Cell Cancers

Recruiting at 14 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: CRISPR Therapeutics AG

Must not be taking: Anticancer biologics, Nonbiological anticancer

Disqualifiers: CNS involvement, Seizure disorder, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CTX112 for individuals with B-cell cancers that have returned or did not improve with other treatments. The main goal is to assess the safety and effectiveness of CTX112 when administered through an IV drip following some chemotherapy. Suitable candidates have B-cell cancer that has recurred or not responded to treatment and are well enough to perform everyday activities. As a Phase 1 trial, this research aims to understand how CTX112 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any nonbiological anticancer drugs at least 14 days before the CTX112 infusion and any anticancer biologics at least 30 days before the infusion.

Is there any evidence suggesting that CTX112 is likely to be safe for humans?

Research has shown that CTX112, a treatment for B-cell cancers, is generally safe based on early studies. These findings suggest that most patients tolerate the treatment well, with few serious side effects. Although specific details about side effects are not provided, CTX112 is viewed as having the potential to offer significant health benefits. Since this study is in the early stages (Phase 1/2), it primarily focuses on safety, so any major safety issues would likely be identified at this stage. Participants can therefore expect that the treatment is considered generally safe at the doses being tested. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CTX112 is unique because it uses CRISPR gene-editing technology to engineer T-cells that can better recognize and attack cancerous B-cells. Unlike traditional chemotherapy or monoclonal antibodies, CTX112 is administered via IV infusion after specific chemotherapy that prepares the body to receive these modified cells. Researchers are excited because this approach has the potential to provide a more targeted attack on cancer cells, possibly leading to better outcomes with fewer side effects.

What evidence suggests that CTX112 might be an effective treatment for B-cell cancers?

Research has shown that CTX112 is a promising treatment for B-cell cancers. Studies have found that CTX112, which uses advanced CRISPR-Cas9 technology, can be very effective for these cancers. Early results suggest that CTX112 offers significant benefits and is generally well-tolerated by patients. It has performed better than previous similar treatments, even at low doses. These encouraging early findings suggest that CTX112 could improve outcomes for patients whose B-cell cancers have returned or are not responding to other treatments. ^{1 2 3 5 6}

Who Is on the Research Team?

Melanie Allen, M.Sc.

Principal Investigator

CRISPR Therapeutics

Are You a Good Fit for This Trial?

Adults over 18 with certain B-cell cancers that have come back or didn't respond to treatment can join. They must be fairly active and healthy, with good heart, kidney, liver, and lung function. Participants need to use birth control during the trial and for a year after getting the study drug.

Inclusion Criteria

My kidney, liver, heart, and lung functions are all good.

My B cell cancer has returned or is not responding to treatment.

I am fully active or can carry out light work.

Exclusion Criteria

I have had a stem cell transplant from a donor.

I have an ongoing serious infection needing IV treatment.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy prior to CTX112 infusion

1-2 weeks

Treatment

Participants receive CTX112 via IV infusion

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

What Are the Treatments Tested in This Trial?

Interventions

• CTX112

Trial Overview The trial is testing CTX112's safety and effectiveness in patients with various types of B-cell malignancies that are resistant or have relapsed. It's an early-phase study where everyone gets the same experimental therapy.

How Is the Trial Designed?

Group I: CTX112 Experimental Treatment 1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

Who Is Running the Clinical Trial?

CRISPR Therapeutics AG

Lead Sponsor

Trials

9

Recruited

640+

Published Research Related to This Trial

In a study of 23,296 patients from 202 clinical trials, women were found to have a 34% higher risk of experiencing severe adverse events (AEs) from cancer treatments compared to men, with the risk increasing to 49% for those receiving immunotherapy.

Women experienced significantly more severe symptomatic and hematologic AEs across all treatment types, particularly with immunotherapy, highlighting the need for further research into sex differences in treatment responses and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials. Unger, JM., Vaidya, R., Albain, KS., et al.[2022]

A large-scale analysis of 16,196 serious adverse drug reaction reports identified 36 potential safety signals associated with ibrutinib, including ischemic heart diseases and fractures, highlighting the need for careful patient monitoring.

The study found that over half of the reports resulted in hospitalization, indicating that while ibrutinib is a standard treatment for B-cell malignancies, its safety profile requires further investigation to confirm these findings in broader populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database. Allouchery, M., Tomowiak, C., Lombard, T., et al.[2021]

A review of 166 phase III randomized clinical trials published between 2011 and 2013 revealed frequent misreporting of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0), indicating a significant issue in adherence to established guidelines.

Inappropriate grading of toxicities was common, with serious conditions like febrile neutropenia often graded too low, and less severe conditions like alopecia graded too high, which could mislead clinicians and affect treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and misuse of common terminology criteria for adverse events in cancer clinical trials. Zhang, S., Liang, F., Tannock, I.[2018]

A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.

The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. Wang, Z., Yang, X., Wang, J., et al.[2020]

The Common Terminology Criteria for Adverse Events (CTCAE) has evolved through multiple versions to standardize the reporting of adverse events in clinical trials, improving accuracy and completeness.

However, the current version (CTCAE 3.0) is insufficient for coding subacute adverse events associated with modern targeted therapies, indicating a need for further updates to better capture these specific side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there room for improvement in adverse event reporting in the era of targeted therapies? Edgerly, M., Fojo, T.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05643742

A Safety and Efficacy Study Evaluating CTX112 in Subjects ... This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.

2. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4829/533290/CTX112-a-Next-Generation-Allogeneic-CRISPR-Cas9

CTX112, a Next-Generation Allogeneic CRISPR-Cas9 ... These data demonstrate that CTX112 has the potential to be a highly effective allogeneic CAR T cell therapy for B-cell malignancies.

3. ir.crisprtx.com ir.crisprtx.com/news-releases/news-release-details/crispr-therapeutics-presents-data-2024-american-society

CRISPR Therapeutics Presents Data at the 2024 American ... These preliminary data demonstrate that CTX112 has the potential to provide meaningful clinical benefit with a well-tolerated safety profile.

4. bloodcancerstoday.com bloodcancerstoday.com/post/ctx112-yields-clinically-meaningful-results-in-relapsed-or-refractory-b-cell-malignancies

CTX112 Yields Clinically Meaningful Results in Relapsed ... CTX112 has shown better efficacy than first-generation allogeneic CAR T-cell therapies at low doses, in patients with relapsed or refractory ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124075876

CTX112, a Next-Generation Allogeneic CRISPR-Cas9 ... These data demonstrate that CTX112 has the potential to be a highly effective allogeneic CAR T cell therapy for B-cell malignancies. Recommended articles ...

6. clinicaltrial.be clinicaltrial.be/en/details/263418?per_page=100&only_recruiting=0&only_eligible=0

A Safety and Efficacy Study Evaluating CTX112 in Subjects... Trial description. This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies.